Ivabradine Zentiva: detailed information

Package leaflet: Information for the patient

Ivabradina Zentiva 5 mg film-coated tablets, 7.5 mg film-coated tablets

ivabradine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ivabradina Zentiva is and what it is used for
What you need to know before taking Ivabradina Zentiva
How to take Ivabradina Zentiva
Possible side effects
How to store Ivabradina Zentiva
Contents of the pack and other information

1. What Ivabradina Zentiva is and what it is used for

Ivabradina Zentiva (ivabradine) is a heart medication used to treat:

Symptomatic stable angina (a disease causing chest pain) in adult patients whose heart rate is greater than or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take heart medications called β-blockers. It is also used in combination with β-blockers in adult patients whose condition is not fully controlled with a β-blocker.
Chronic heart failure in adult patients whose heart rate is greater than or equal to 75 beats per minute. It is used in combination with standard therapy, which includes treatment with a β-blocker, or when β-blockers are contraindicated or not tolerated.

Information on stable angina (commonly referred to as "angina")
Stable angina is a heart disease that occurs when the heart does not receive enough oxygen.
The most common symptom of angina is pain or discomfort in the chest.

Information on chronic heart failure
Chronic heart failure is a heart disease that occurs when the heart is unable to pump enough blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivabradina Zentiva works
The specific heart rate-lowering effect of ivabradine helps:

control and reduce the number of angina attacks by decreasing the heart's oxygen demand,
improve heart function and life expectancy in patients with chronic heart failure.

2. What you should know before taking Ivabradina Zentiva

Do not take Ivabradina Zentiva

if you are allergic to ivabradine or to any of the excipients of this medicine (listed in section 6).
if your resting heart rate before treatment is too low (less than 70 beats per minute).
if you are suffering from cardiogenic shock (a heart condition treated in hospital).
if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, third-degree AV block).
if you are having a heart attack.
if you have very low blood pressure.
if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion).
if you have heart failure that has recently worsened.
if your heartbeat is paced exclusively by a pacemaker.
if you have severe liver problems.
if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin) or medicines for treating HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris).
if you are a woman able to have children and are not using appropriate contraception.
if you are pregnant or trying to become pregnant.
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradina Zentiva.

if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome".
if you become easily tired, feel dizzy or have shortness of breath (this could mean your heart is beating too slowly).
if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without apparent reason, making it difficult to measure).
if you have recently had a stroke (cerebral attack).
if you have mild to moderate low blood pressure.
if you have uncontrolled blood pressure, particularly following a change in antihypertensive treatment.
if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block".
if you have a chronic disease of the retina.
if you have moderate liver problems.
if you have severe kidney problems.

If any of the conditions listed above apply to you, discuss them immediately with your doctor before or during treatment with Ivabradina Zentiva.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. Available data are insufficient in this age group.
Other medicines and Ivabradina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to monitor or adjust the dose of Ivabradina Zentiva:

fluconazole (an antifungal medicine).
rifampicin (an antibiotic).
barbiturates (for insomnia or epilepsy).
phenytoin (for epilepsy).
Hypericum perforatum or St. John's wort (herbal remedy used for depression).
medicines that prolong the QT interval used to treat rhythm disorders or other conditions such as:
- quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders).
- bepridil (to treat angina pectoris).
- certain types of medicines used to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole).
- medicines for malaria (such as mefloquine or halofantrine).
- intravenous erythromycin (an antibiotic).
- pentamidine (an antiparasitic agent).
- cisapride (used for gastro-oesophageal reflux).
certain types of diuretics that may cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Ivabradina Zentiva with food and drink
Avoid grapefruit juice during treatment with Ivabradina Zentiva.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ivabradina Zentiva if you are pregnant or planning a pregnancy (see "Do not take Ivabradina Zentiva").
If you become pregnant while taking Ivabradina Zentiva, speak to your doctor.
Do not take Ivabradina Zentiva if you are able to have children unless you are using appropriate contraceptive measures (see "Do not take Ivabradina Zentiva").
Do not take Ivabradina Zentiva if you are breastfeeding (see "Do not take Ivabradina Zentiva"). Discuss with your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued during treatment with Ivabradina Zentiva.
Driving and using machines
Ivabradina Zentiva may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or using machines, especially when there may be sudden changes in light intensity, particularly during night driving.

3. How to take Ivabradina Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

If you are being treated for stable angina pectoris
The initial dose must not exceed one tablet of Ivabradina Zentiva 5 mg twice daily. If your angina symptoms
persist and you tolerate the daily dose of 5 mg twice daily well, the dose may be increased. The maintenance
dose must not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate dose for you. The
usual dose is one tablet in the morning and one tablet in the evening.
In some cases (e.g. if you are 75 years of age or older), your doctor may prescribe half the dose, e.g. half a
5 mg Ivabradina Zentiva tablet (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the
evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Zentiva 5 mg twice daily, which may be
increased if necessary to one tablet of Ivabradina Zentiva 7.5 mg twice daily. Your doctor will decide the most
appropriate dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some
cases (e.g. if you are elderly), your doctor may prescribe half the dose, i.e. half a 5 mg Ivabradina Zentiva
tablet (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Method of administration
The tablets must be taken orally twice daily, for example with meals, one in the morning and one in the evening.
Ivabradina Zentiva 5 mg film-coated tablets may be divided into two equal doses.
Use a tablet cutter to divide the tablet.

If you take more Ivabradina Zentiva than you should
A high dose of Ivabradina Zentiva may make you feel breathless or tired due to excessive slowing of the
heart rate. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Zentiva
If you forget to take a dose of Ivabradina Zentiva, take the next dose at your usual scheduled time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Ivabradina Zentiva
Since treatment for angina or chronic heart failure is usually lifelong, you must speak with your doctor before
stopping this medicine.

If you feel that the effect of Ivabradina Zentiva is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:
Very common (may affect more than 1 in 10 people)

Visual disturbances involving light (brief moments of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These phenomena generally occur within the first two months of treatment and may then recur repeatedly, resolving during or after treatment.

Common (may affect up to 1 in 10 people)

Changes in heart function (symptoms include slowed heart rate). These effects occur particularly within the first 2–3 months after starting treatment.

Other side effects have also been reported:
Common (may affect up to 1 in 10 people)

Rapid and irregular heartbeat (atrial fibrillation), abnormal awareness of heartbeat (bradycardia, ventricular extrasystoles, first-degree AV block (prolonged PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people)

Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle spasms, high blood levels of uric acid, excess of eosinophils (a type of white blood cells), elevated creatinine (a product of muscle breakdown) in the blood, skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal ECG tracing, double vision, weakened vision.

Rare (may affect up to 1 in 1,000 people)

Urticaria, itching, skin redness, malaise.

Very rare (may affect up to 1 in 10,000 people)

Irregular heartbeat (second- and third-degree AV block, sick sinus syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ivabradina Zentiva contains

The active substance is ivabradine (as hydrochloride). Each film-coated tablet contains 5 mg of ivabradine (as hydrochloride) or 7.5 mg of ivabradine (as hydrochloride).
The other components are:
- tablet core: mannitol, crospovidone (type A), magnesium stearate
- film coating: hypromellose (6 mPa·s, type 2910), titanium dioxide (E 172), macrogol 400, glycerol (E422).

Description of the appearance of Ivabradina Zentiva and package contents
Ivabradina Zentiva 5 mg film-coated tablets are white, round, biconvex tablets with a deep break line on one side and "5" engraved on the other, with a diameter of 6.5 mm. The tablets can be divided into two equal doses.
Ivabradina Zentiva 7.5 mg film-coated tablets are white to off-white, round tablets with a diameter of 7.1 mm.
Ivabradina Zentiva is packaged in cardboard boxes with blisters made of OPA/Alu/PVC-Alu.
The tablets are available in packs of 14, 28, 56, 84, 98, 100, 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer(s)
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic
or
S.C. Zentiva S.A
50 Theodor Pallady Blvd,
District 3,
032266 Bucharest
Romania

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 280 86 420 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +359 2 441 7136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2778 0890
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +47 219 66 203
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva, k.s. Zentiva Polska Sp. z o.o.
Tel: +34 931 815 250 Tel: +48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351 210 601 360
[email protected] [email protected]

Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 0650 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39-02-38598801 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +357 240 30 144 Tel: +46 840 838 822
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Zentiva, k.s. Zentiva, k.s.
Tel: +371 67893939 Tel: +44 (0) 800 090 2408
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.